• Pediatric and adolescent COVID-19 vaccination side effects: A retrospective cohort study of the Iranian teenage group in 2021
  • Nader Tavakoli,1 Nahid Nafissi,2 Sima Shokri,3 Morteza Fallahpour,4 Azadeh Goodarzi,5,* Sanaz Soleimani,6
    1. Department of Emergency Medicine, School of Medicine, Trauma and Injury Research Center, Iran University of Medical Sciences, Tehran, Iran
    2. Department of General Surgery, Rasool-e Akram Medical Complex Clinical Research Development Center (RCRDC), Iran University of Medical Sciences, Tehran, Iran.
    3. Department of Allergy and Clinical Immunology, Rasool-e Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran;
    4. Department of Allergy and Clinical Immunology, Rasool-e Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran;
    5. a, Department of Dermatology, Rasool-e Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran; / b, Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran
    6. Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran / Rasool-e Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran


  • Introduction: On February 19, 2020, the first case of COVID-19 was announced in Iran, and COVID-19 development was reported in 8.5 million cases since the beginning of pandemic about 125,000 deaths. Hence, the need for medical, social and economic response to COVID-19 epidemic led to the rapid development and production of a large number of vaccines. Recent studies have all documented the immunogenicity of the vaccine in adults and the elderly, and only a handful of studies have examined the efficacy of these vaccines in children. Therefore, one of the most controversial issues is the vaccination of people under 18 years of age. Regarding the start of vaccination of children in Iran, we examined the safety and possible side effects of vaccination under 18 years to provide a safe and effective vaccine. This study is one of the national studies with large sample size aimed to evaluate safety and efficacy (regarding the break-through infection) of COVID-19 vaccination in Iranian children and adolescents.
  • Methods: In this retrospective cohort study, contact numbers of parents of teenagers under 18 years of age referred to a teenager vaccination centers in Tehran-Iran to receive the corona vaccine were collected and following information were obtained via the phones:demographic information, type of vaccine and number of doses received, and additional information,like complications, required treatments.
  • Results: 11,042 subjects aged 10-18 years, mean age 14.55±1.83 years, including 5374 boys and 5768 girls were investigated. 88.1% received the Sinopharm and 11.9% the Soberana vaccine. General side effects, including fatigue, fever and chills, injection site pain and dizziness, etc. happened in 2978 cases, 7421 children presented with at least one general or organ-specific side effect following vaccination, including potentially critical side effects,such as vascular injuries, respiratory complication, etc.0.1% of the subject needed hospital admission. The breakthrough infection happened in 200 individuals.
  • Conclusion: Our study shows that Sinopharm and Soberana (PastoCoVac) COVID-19 vaccine are generally safe with no serious side effects in fewer than 18 years old. COVID19 infection and reinfection can occur after vaccination, but the incidence is actually tolerable and significantly lower than in the unvaccinated group.
  • Keywords: Safety, Efficacy, Vaccination, COVID-19, Children